Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial

Aim Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has...

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Authors: Romaguera, Rafael, Salinas, Pablo, Gomez-Lara, Josep, Brugaletta, Salvatore, Gomez-Menchero, Antonio, Romero, Miguel A., Garcia-Blas, Sergio, Ocaranza, Raymundo, Bordes, Pascual, Jimenez Kockar, Marcelo, Salvatella, Neus, Jimenez-Diaz, Victor A., Gomez-Hospital, Joan A., Alameda Ortiz, Maria Del Mar, Trillo, Ramiro, Lee, Dae Hyun, Martin, Pedro, Lopez-Benito, Maria, Freites, Alfonso, Pascual-Tejerina, Virginia, Hernandez-Hernandez, Felipe, Garcia Del Blanco, Bruno, Mohandes, Mohsen, Bosa Ojeda, Francisco, Pinar, Eduardo, Roura, Gerard, Comin-Colet, Josep, Fernandez-Ortiz, Antonio, SUGAR Trial Investigators, Macaya, Carlos, Rosselló, Xavier, Sabate, Manel, Pocock, Stuart J.
Format: article
Publication Date:2022
Country:España
Institution:Conselleria de Salut i Consum del Govern de les Illes Balears
Repository:Docusalut
Language:English
OAI Identifier:oai:docusalut.com:20.500.13003/19436
Online Access:https://hdl.handle.net/20.500.13003/19436
Access Level:Open access
Keyword:Diabetes Mellitus
Treatment Outcome
Humans
Coronary Artery Disease
Prosthesis Design
Drug-Eluting Stents
Percutaneous Coronary Intervention
Sirolimus
Resultado del Tratamiento
Stents Liberadores de Fármacos
Humanos
Enfermedad de la Arteria Coronaria
Intervención Coronaria Percutánea
Diseño de Prótesis
Percutaneous coronary intervention
Drug-eluting stents
Diabetes mellitus
Randomized trial
Description
Summary:Aim Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes. Methods and results We did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR): 0.65, 95% confidence interval (CI): 0.44-0.96; Pnon-inferiority < 0.001; P-superiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs. 11.1%, HR: 0.67, 95% CI: 0.46-0.99; P = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups. Conclusion In patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome.

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